Takehome:
- The newly revised “Implementation Rules of Food Safety Law” further details requirements for health food management in China including health food raw material and function directory, health food manufacturer requirements and retail requirements.
Recently, the newly revised “Implementation Rules of Food Safety Law” was released (see CL news report on Oct. 21, 2016), which further clarifies the requirements for health food management in China, including the management of health food raw materials, health food function claims, etc. as the basis of the implementation of China’s health food registration and filing system.
Health food raw material directory
Approved health food raw materials are included in an inventory which is subject to strict standards. Using a health food raw material from this inventory requires complete compliance with the manufacturing, dosage, efficacy and other technical requirements. It is stipulated in the “Implementation Rules of Food Safety Law” that the health food raw material directory should be published together with the corresponding dosage, efficacy as well as relevant technical requirements including the production technique, functional component and test method of the raw materials.
If a manufacturer alters raw material composition, dosage or the corresponding efficacies beyond stipulated parameters and/or changes a production technique then the ingredient will not be considered approved and will not be subject to the facilitated regulatory measures associated with using ingredients from this directory.
The raw materials for foods with specific health functions other than nutrient supplements shall be managed as health food raw materials and are not permitted for approval as new food raw materials. Conventional foods cannot contain any of the raw materials approved for health foods.
For nutrient supplements imported for the first time, all the nutrient substances shall be included into the approved health food raw material directory.
Currently, CFDA has drafted the first batch of health food raw materials and auxiliary materials:
- The draft of the first batch of health food raw materials (see CL news report on Jun. 3, 2016)
- The draft of the first batch of health food auxiliary materials (see CL news report on May 31, 2016)
Health food function directory
Only the function claims approved in health food registration/filing certificate are allowed to be indicated on label and user’s directions. Any other conventional foods other than health food are prohibited to indicate any functional claims in any form. Currently, there are 27 approved health food function claims.
Requirements for health food manufacturers
Health food manufacturers using raw material pretreatment and/or purification processes during production shall ensure that material pretreatment capabilities match their product variety and production scale. Manufacturers engaged in the production, processing and sale of health food premix and extracts shall be involved in the health food production licensing procedure.
Requirements for sale of health food
Furthermore, it is required in the regulation that health food shall be sold in special areas in shops, and shall not be sold together with other conventional foods and drugs. There should be special indication in the sale area that “this product cannot be a substitute of drugs”.